RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known which vaccine is most effective in treating breast cancer.

PURPOSE: This randomized clinical trial is studying the side effects of three different vaccine therapies and comparing the vaccines to see how well they work in treating patients with previously treated stage II or stage III breast cancer.

Number and severity of hematologic and non-hematologic toxicities reported using the NCI-CTC version 3.0 criteria [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Disease-free survival, defined as the time from registration to the documentation of a first failure where a failure is the recurrence of breast cancer or a diagnosis of a second primary cancer [ Designated as safety issue: No ]

Overall survival, defined as the time from registration to death due to any cause [ Designated as safety issue: No ]

Estimated Enrollment:

45

Study Start Date:

August 2008

Estimated Primary Completion Date:

May 2016 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To determine the safety and immunization efficacy of MUC1 and HER-2/neu peptide vaccines combined with CpG oligodeoxynucleotide, sargramostim (GM-CSF), or both, as immune adjuvants suspended in Freund's incomplete adjuvant in patients with previously treated stage II or III adenocarcinoma of the breast.

Secondary

To describe the impact of immunization on clinical outcomes in patients with MUC1-positive breast cancer in terms of disease-free survival and overall survival.

OUTLINE: Patients are stratified according to Her-2/neu status (positive vs negative). Patients are randomized to 1 of 3 treatment arms.

Arm B: Patients receive a vaccine comprising incomplete Freund's adjuvant, MUC1 antigen vaccine, two Her-2/neu peptide-based vaccines (one of them different than in arm A), and CpG oligodeoxynucleotide SC on day 1.

Arm C: Patients receive a vaccine comprising incomplete Freund's adjuvant, MUC1 antigen vaccine, two Her-2/neu peptide-based vaccines (one of them different than in arm A; the same as in arm B), GM-CSF, and CpG oligodeoxynucleotide SC on day 1.

In all arms, treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who complete 6 courses of treatment without disease recurrence or a second primary or intolerable toxicity will go to the observation phase of the study for up to 2 years. Patients who develop recurrent disease during the observational phase will go to the event monitoring phase for up to 2 years.

Blood samples are collected periodically. Blood samples and tissue samples from the patient's most recent surgery are used for correlative studies including immune responses to T helper and CTL epitopes by Elispot and tetramer analysis; and antigenic profiling by expression analysis of class I HLA antigens, MUC1, and HER-2 in tumor tissue.

After completion of study treatment, patients are followed periodically until disease recurrence or for up to 2 years.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the breast

Clinical stage II or III disease

No radiographic evidence of disease at the time of enrollment

Has undergone surgery, adjuvant chemotherapy, and/or radiotherapy

Completed "standard first-line therapy" only (including adjuvant therapy) for breast cancer within the past 3 months and currently with no evidence of disease

Patients with stage I breast cancer with high-risk features are eligible provided 1 of the following criteria are met:

HER2 over-expression or amplification

Triple-negative (i.e., no expression of ER, PR, or over-expression of HER2 on routine immunohistochemical staining)

.

MUC1-positive breast cancer

HLA-A2 positive

Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Menopausal status not specified

ECOG performance status 0-2

Hemoglobin ≥ 8.0 g/dL

Platelet count ≥ 75,000/μL

ANC ≥ 1,500/uL

Creatinine ≤ 2 times upper limit of normal (ULN)

AST ≤ 2 times ULN

No uncontrolled infection

No known HIV infection

No other circumstances (e.g., concurrent use of systemic immunosuppressants or immunocompromising condition) that in the opinion of the physician would render the patient a poor candidate for this trial

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception

No prior invasive malignancies within the past 5 years (with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix)

No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)

No concurrent enrollment in any other study involving a pharmacologic agent (drugs, biologics, immunotherapy approaches, gene therapy) whether for symptom control or therapeutic intent

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640861